DakoCytomation Beta-2-Microglobulin Kit is intended for the quantitative determination of beta-2-microglobulin in human serum and plasma by rate nephelometry on IMMAGE® Immunochemistry Systems. Measurement of beta-2-microglobulin aids in the diagnosis of patients with active rheumatoid arthritis and kidney disease.

Device Description

DakoCytomation Beta-2-Microglobulin Kit is an in vitro diagnostic assay device for the quantitative determination of human beta-2-microglobulin. Beta-2-microglobulin (B2M), a low molecular weight polypeptide of 11,800 daltons, is the light chain component of the major histocompatibility antigen (HLA). B2M is present on the membrane surface of all cells that express major histocompatibility antigens and it is normally present in the circulation as a result of cell membrane turnover.

The Beta-2-Microglobulin device is similar in design, materials and intended use to other 510(k) cleared devices, which are in commercial distribution.

AI/ML Overview

The provided document is a 510(k) summary for the DakoCytomation Beta-2-Microglobulin Kit. It describes the device's intended use and demonstrates its substantial equivalence to a predicate device. However, it does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.

Here's an breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "significant interference is defined as recovery within $\pm$ 10% at β2M > 6 mg/L or within $\pm$ 0.6 mg/L at β2M ≤ 6 mg/L" for interfering substances. This can be considered an acceptance criterion for interference.

Acceptance Criteria	Reported Device Performance
Interfering Substances: No significant interference defined as recovery within $\pm$ 10% at β2M > 6 mg/L or within $\pm$ 0.6 mg/L at β2M ≤ 6 mg/L.	Hemoglobin concentrations up to 1000 mg/dL, bilirubin (conjugated) up to 60 mg/dL and triglyceride up to 1500 mg/dL do not significantly interfere with the assay.
Lower Detection Limit (Serum):	0.3 mg/L
Assay Range (Serum):	0.3 to 20 mg/L

Note: The document states that the new device meets these criteria but does not provide raw data or specific study results beyond stating that "do not significantly interfere." It primarily focuses on comparing features with the predicate device.

2. Sample size used for the test set and the data provenance:

Not explicitly stated. The document describes the device and its intended use, and compares it to a predicate. It mentions interference studies but does not provide sample sizes or the origin (country) of the data, nor whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not stated. This device is an in vitro diagnostic kit, not an AI-powered diagnostic tool requiring expert interpretation of images or other subjective data for "ground truth" establishment in a traditional sense. The "ground truth" for this type of device would typically be established through analytical validation studies against reference methods or clinical samples with known analyte concentrations, not through expert consensus on interpretations.

4. Adjudication method for the test set:

Not applicable / Not stated. See explanation for #3. Adjudication methods are relevant for subjective interpretations, which is not the primary output for this type of quantitative assay.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is an in vitro diagnostic kit, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, in essence. The DakoCytomation Beta-2-Microglobulin Kit is a standalone diagnostic assay (an algorithm in this context refers to the chemical reactions and measurement principles), and its performance is evaluated independently. The device's output (quantitative beta-2-microglobulin levels) is directly used for diagnosis, not as an aid for human interpretation in the way AI imaging tools are used.

7. The type of ground truth used:

For an in vitro diagnostic assay like this, the "ground truth" is typically established through:
- Reference methods: Comparing results to a gold standard method for measuring beta-2-microglobulin.
- Known concentration samples: Testing samples with precisely determined concentrations of beta-2-microglobulin.
- Clinical samples with established clinical diagnoses: While the assay aids in diagnosis, its accuracy is validated by its ability to correctly quantify the analyte in samples from patients with and without the conditions of interest (rheumatoid arthritis, kidney disease) where the true B2M levels are well-characterized.
The document implies that the device accurately measures beta-2-microglobulin, which is the underlying "ground truth" it's designed to detect.

8. The sample size for the training set:

Not applicable / Not stated. This device is a chemical assay kit, not a machine learning or AI model that requires a "training set" in the computational sense. Its performance is based on its chemical and immunological principles, not on being trained on a dataset.

9. How the ground truth for the training set was established:

Not applicable / Not stated. (See explanation for #8).

Summary

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1 510(k) Summary
November 25, 2003 Date of Summary Preparation: Ms. Gitte Brinkmann 1.2 Submitter:

DakoCytomation Denmark A/S. Produktionsvej 42 DK-2600 Glostrup Denmark

DakoCytomation Beta-2-Microglobulin Kit. 1.3 Trade Name:
Classification Name, Product Code, Class, Classification Reference: 1.4

Classification Name	Product Code	Class	21CFR §
System, Test, Beta-2-Microglobulin Immunological	JZG	II	866.5630

Standards/Special Controls: 1.5

None

Indications for Use: 1.6

For in vitro diagnostic use.

1.7 Device Description:

The Beta-2-Microglobulin device is similar in design, materials and intended use to other 510(k) cleared devices, which are in commercial distribution.

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Substantially Equivalent Commercially Available Devices: 1.8

The Beta-2-Microglobulin device is substantially equivalent to the predicate device described herein with respect to indications for use, device design, materials, and method of manufacture: IMx B2 Microglobulin - K890421

The predicate device is commercially available and a marketed Class II device indicated for use for the quantitative measurement of beta-2-microglobulin in human serum, plasma or urine.

Substantial Equivalence Comparison: 1.9

Beta-2-Microglobulin is similar to commercially available device with respect to intended use, material, design and operational principles as follows:

Similarities
Feature	New deviceDakoCytomation Beta-2-Microglobulin Kit	Predicate deviceIMx B2 Microglobulin
Intended Use	Quantitative determinationof beta-2-microglobulin inhuman serum and plasmaby rate nephelometry onIMMAGE®ImmunochemistrySystems. Measurementof beta-2-microglobulinaids in the diagnosis ofpatients with activerheumatoid arthritis andkidney disease.	Quantitative measurementof beta-2-microglobulin inhuman serum, plasma orurine to be used as an aidin the management ofpatients with renaldysfunction or rheumatoidarthritis
Sample Type	Serum, plasma	Serum, plasma, urine

ableT
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Feature	New deviceDakoCytomation Beta-2-Microglobulin Kit	Predicate deviceIMx B2 Microglobulin
Interfering Substances	Hemoglobinconcentrations up to 1000mg/dL, bilirubin(conjugated) up to 60mg/dL and triglyceride upto 1500 mg/dL do notsignificantly interfere withthe assay.No significant interferenceis defined as recoverywithin $\pm$ 10% at β2M > 6mg/L or within $\pm$ 0.6 mg/Lat β2M ≤ 6 mg/L.	Hemoglobinconcentrations up to 1000mg/dL, bilirubin(conjugated) up to 41.9mg/dL and triglyceride upto 1023 mg/dL do notsignificantly interfere withthe assay
Specificity	b-2-microglobulin	b-2-microglobulin
Reagents/Calibrators/Controls	Liquid stable	Liquid stable

Feature	DakoCytomation Beta-2-Microglobulin Kit	IMx B2 Microglobulin
Instrument Required	Beckman Coulter IMMAGE	Abbott IMx
Antibody	Polyclonal	Monoclonal
Sample type	Serum, plasma	Serum , plasma and urine
Reaction Test Principle	Nephelometry	MEIA
Assay Type	Homogenous Immunoassay	HeterogenousImmunoassay
Lower Detection Limit(Serum)	0.3 mg/L	0.05 mg/L
Assay Range (Serum)	0.3 to 20 mg/L	0 to 40 mg/L

Indications and Contraindications:

Relative indications and contraindications for DakoCytomation Beta-2-Microglobulin Kit and commercially available devices for similar intended uses are the same.

Conclusion: 1.11

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, DakoCytomation concludes that the new device, DakoCytomation Beta-2-Microglobulin Kit, is safe, effective and substantially equivalent to the predicate device as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 2 2004

Ms. Gitte Brinkmann QA Professional DakoCytomation Denmark A/S Produktionsvej 42 DK-2600Glostrup Denmark CVR N0. 33 21 13 17

K032692 Re:

Trade/Device Name: DakoCytomation Beta-2-Microglobulin Kit Regulation Number: 21 CFR 866.5630 Regulation Name: Beta-2-microglobulin immunological test system Regulatory Class: Class II Product Code: JZG Dated: November 25, 2003 Received: November 28, 2003

Dear Ms. Brinkmann:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Aven Autman, m.D.

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number: K032692

Statement of Indication for Use

Device Name: DakoCytomation Beta-2-Microglobulin Kit

Indications for Use:

For in vitro diagnostic use.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. Reeves

sion Sign-O Division of Clinical Laboratory Devices

510(k) Number k 0 3 26 62

Prescription Use V

Over-The-Counter Use ___

Regulation Number and Section

§ 866.5630

Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.